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July 25, 2013

BIO IPDx Symposium Highlights Uncertainty in Diagnostic Patenting

On July 22, BIO hosted the first
IP and Diagnostics (IPDx) Symposium in Alexandria, Virginia, which was
organized to open a dialogue regarding the latest developments in diagnostics
and personalized medicine. The symposium
covered a wide range of topics in the field, including obtaining patent
protection, regulatory & reimbursement, and business development &
strategic deals. Despite the range of
topics, one unifying theme applying to all aspects of this burgeoning field is uncertainty.

Patent protection in
diagnostics is crucial, for there is no market or data exclusivity attributed
to diagnostic testing. Industry members must
attempt to predict at an early stage whether patent protection over a
diagnostic can be achieved, and if the prediction is negative, the diagnostic
may not be pursued. This prediction has
become much more difficult recently, and not unexpectedly at the forefront of
the symposium discussion was the impact of the recent Supreme Court decisions
in Mayo and Myriad. The first panel,
moderated by Patent Docs author Donald Zuhn of MBHB, was comprised of Patent Docs author Kevin Noonan of
MBHB, Duane Marks of Roche Diagnostics, and Mary Till of the USPTO, with
each panelist providing their recommendations on how to successfully navigate
patent prosecution under the limitations imposed by these Court decisions. Drafting claims to recite method of treatment
steps or to include non-natural compositions (such as the transformed cells
from claim 20 in Myriad) were two
potential strategies discussed that may avoid § 101 scrutiny under Mayo and Myriad.

Of course, Myriad
explicitly exempts cDNA from § 101 scrutiny, which came as a relief to many
sectors of biotechnology, who consider cDNA as (arguably) the most commercially
important aspect of so-called "gene patents." However, the scope of the Myriad decision was the topic of debate
between the panelists and audience members. While there was agreement that the Myriad holding is not limited to
human DNA, there was spirited disagreement regarding its long-term impact on
patents claiming naturally occurring DNA. On the one hand, it is true that the
vast majority of patents covering human DNA are nearing the end of their
lifespan, thus reducing the significance of the Myriad opinion here. However, on the other hand, the biotechnology industry must consider the
possible ramifications beyond human genes, particularly in sectors like
biofuels that rely on lower-order organisms. Since the genes of these lower-order organisms often lack introns,
claims directed to their cDNA will not fall within the exception stated in
Myriad.

Further, under Myriad, there are questions regarding
the fate of isolated polypeptides, stem cells, and all other compositions based
on natural products. These compositions
represent platform technologies for many biotech firms, and this uncertain
climate is causing hesitation disclosing such technologies in patent
applications. The risk of failing to
secure adequate patent protection may be too great. The panelists noted the possibility that the
biotechnology industry shifts away from patenting diagnostic products, moving
instead towards the trade-secret and/or service provider model. In this model, samples would be tested
in-house, and the biotech company would keep the biomarker information and
diagnostic algorithms as trade secrets. This
in-house testing model may also have the added benefit of avoiding any future FDA
regulation of such diagnostic testing, which represents another unsettled issue
in the field of diagnostics discussed at the Symposium.